K250267

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)

510(k) number: K250267
Device name: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
Applicant: Kettenbach GmbH & Co. KG DE
Product code: EBF — Material, Tooth Shade, Resin
Decision date: 2025-03-14
Date received: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Dental

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K250267.pdf

Official FDA record: K250267

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.